Emisphere completes enrollment for phase 2 oral insulin clinical trial

By Lisa Kerner

Erie, Pa., April 11 - Emisphere Technologies, Inc. said it has completed enrollment of the first 120 patients in its phase 2 oral insulin clinical trial.

Enrollment in the 90-day, multi-center, randomized trial began in November, according to a company news release.

The study will evaluate the safety and efficacy of low and high fixed doses of oral insulin tablets versus a placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with existing oral metformin monotherapy.

The primary efficacy endpoint of the trial is related to the change in hemoglobin A1c.

The company has received permission from regulatory authorities in India to expand the trial enrollment to 140 patients from 120 patients in order to better evaluate all three active arms of the trial for statistical significance, according to a company news release.

Without the additional patients, Emisphere said it would be limited to evaluating each of the active arms against only the placebo for statistical significance.

"Expanding our trial enrollment will give us a more robust data set to compare the three different dosing regimens of oral insulin being tested in this trial," chairman and chief executive officer Michael M. Goldberg said in the release.

"We are pleased with the safety and activities observed to date, and are delighted that the DCGI granted us permission to increase enrollment. We expect to complete the trial, and look forward to un-blinding and reporting the results during the second half of this year."

Blinded data from the trial as of April 1 revealed that 59 patients have had their 30-day visit, 22 patients have had their 60-day visit, and a small number of patients have completed the end-of-study 90-day visit.

Emisphere said it is encouraged by the number of patients showing a greater than 1% drop in their hemoglobin A1c at 60 days, with no reported cases of treatment-related serious adverse events or hypoglycemia.

Emisphere is a Tarrytown, N.Y.-based biopharmaceutical company specializing in the oral delivery of otherwise injectable drugs.

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